A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

Study Identifier:
CCD-0705-PR-0027
ClinicalTrials.gov Identifier:
NCT00862394
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: BDP/Formoterol Next DPI
  • Drug: Foster
Date
Feb 2009 - Oct 2009
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Written informed consent
  • Outpatients of both sexes, aged \> 12 years
  • Moderate to severe symptomatic asthma
  • Forced expiratory volume in the first second (FEV1) \> 40% and \< 80% of the predicted normal values
  • Reversibility test
  • "Partly controlled" asthma (GINA revised 2006)
  • Patients free of long-acting beta2-agonists (LABAs) treatment
  • Under inhaled corticosteroids (ICS) treatment
  • A minimum inspiratory flow ≥ 40 L/min 10.
  • Non-smokers or ex smokers
  • Asthma Control Questionnaire ACQ score ≥ 1.5
Exclusion Criteria
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception
  • Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
  • History of near fatal asthma
  • Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit
  • Diagnosis COPD
  • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency
  • Diagnosis of restrictive lung disease
  • Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)
  • Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids
  • Allergy to any component of the study treatments
  • Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit
  • Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;
  • Patients with abnormal QTc
Healthy Volunteers
No

Protocol Summary

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Study Locations

Location
Status
Location
Oliver Kornmann - National Coordinator in Germany
Mainz, Germany, 55131
Status
N/A